Manager, GMP Training

General Description:

The Manager, GMP Training is responsible for leading the site-wide GMP training program, serving as the subject matter expert (SME), and ensuring that the training program remains compliant, effective, and inspection-ready.

The incumbent also functions as the site Business Process Lead (BPL) for global GxP training networks, governance forums, electronic Learning Management System (eLMS) initiatives, and harmonization projects, translating global strategies into actionable site-level implementation plans.

This role is located onsite at our Hopewell, NJ site, reporting to the Associate Director, Quality Compliance.

Essential Functions of the Job:

• Lead, maintain, and continuously improve the site GMP Training Program in alignment with company procedures, regulatory expectations, site objectives, and operational needs.

• Serve as SME during regulatory inspections, internal audits, and mock inspection activities.

• Support eLMS implementation and upgrades, including planning, testing and migration.

• Develop and implement a Train-the-Trainer Program.

• Develop and maintain site-, department-, role-, task-, and qualification-based curricula and associated training matrices.

• Lead cross-functional efforts to improve training compliance, reduce overdue training, and enhance overall training effectiveness.

• Establish and maintain training strategies, processes, and governance to ensure employees receive role-appropriate training.

• Develop and monitor training metrics and key performance indicators to identify trends, risks, and improvement opportunities.

• Collaborate with functional areas to investigate training-related deviations, CAPAs, audit observations, and compliance gaps, and ensure appropriate corrective actions are implemented.

• Set standards for training content, effectiveness assessments, and qualification activities.

• Prepare training reports and management-level presentations that communicate program performance, compliance status, and emerging risks.

• Perform other duties as assigned by management.

Qualifications:

• Bachelor's degree in Life Sciences, Quality, Education, Business, or related field with 5+ years of experience in the biotechnology, pharmaceutical, or regulated manufacturing industry, including experience managing GMP training programs required; Master’s degree and 4+ years of related experience preferred.

• Experience leading or managing a GMP training program in a regulated manufacturing environment.

• Strong knowledge of GMP requirements, FDA expectations, and quality systems.

• Experience supporting regulatory inspections, audits, and inspection readiness efforts.

• Knowledge of training effectiveness assessments and risk-based training strategies.

• Experience managing training through major organizational, process, system, or facility changes.

• Excellent organizational, analytical, communication, and project management skills.

• Ability to collaborate effectively with employees and leaders across all organizational levels.

• Strong attention to detail, customer focus, and ability to manage competing priorities and time-sensitive compliance issues.

Computer Skills:

• Extensive experience with a validated eLMS, preferably ComplianceWire.

• Experience electronic document management system, preferably Veeva.

• Advanced proficiency with Smartsheet, Microsoft 365, including, Excel, PowerPoint, Word, Outlook, Teams, and SharePoint.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.